Poor adherence to medication schedules is a recognized medical problem, costing an estimated $100 billion a year (Improving Medication Adherence, Archives of Internal Medicine 2006, 166:1802-1804). Failing to comply with pharmacological therapies leads to over approximately 125,000 deaths in the US each year, twice the number of people killed in automobile accidents (http://www.harrisinteractive.com/news/allnewsbydate.asp?NewsID=904). Almost 30% of all hospital admissions for people over the age of 65 are directly attributable to medication non-compliance (Archives of Internal Medicine 1990; 150: 841-845). Nearly $48 billion in annual costs result from unnecessary medication-induced hospitalization (Archives of Internal Medicine—October 1995). Approximately 40% of people entering nursing homes do so because they are unable to self-medicate in their own homes (Feasibility Study, Biomedical Business International, January 1988). About one-half of the 1.8 billion prescriptions dispensed annually are not taken correctly, contributing to prolonged or additional illnesses (Medications and the Elderly, Ch. 4 pp 67-68, 75).
Care management and Health Plans currently rely on labor-intensive and costly intervention programs to improve medication compliance. Directly Observed Therapy (DOT) programs employ a health care worker to directly administer, observe and document a patient's ingestion of a medication.
Patients who must take medication in pill form often use a multi-compartment pillbox to help organize the task of taking the proper medication at the proper time. Patients who must take many pills per day at different times of the day frequently use a daily manual pillbox that has four compartments for one day. These compartments are designated AM, NOON, PM, Bed, or Breakfast, Lunch, Dinner, Bed, or some other set of designations, for instance, by time. The four compartments may be integral, or may be individual small boxes that are retained in a day-frame, so that each can be individually manipulated. Pill organizers typically may have seven of such daily four compartment boxes, arranged according to the seven days of the week. Such weekly organizers may typically include a frame that removably retains each of seven daily pillboxes, so that each one can be individually removed and manipulated. Rather than four compartments, a daily system may have more or less compartments, depending on the complexity of the patient's medication regime.
Such manual medication systems are simple, and have both advantages and disadvantages. The advantages include that they are inexpensive and relatively easy to set up and use. A patient or a patient's aid determines which medications are required for each day, and the times of the day that they are required. The required pills are placed into the corresponding compartments, the compartments are closed and each day-set is put into the week-frame for safe-keeping. The patient or the patient's aid opens the appropriate compartment at the appointed times, removes the medication, and the patient consumes it. It is refilled with the proper medications at some time before the next day or week when the compartment or day-set is required to be used again and the process begins again. Other advantages are that the day-set or week-frame can be relatively easily transported to accompany the patient if the patient needs to be away from home for a day or more. They can be cleaned relatively easily. They are arranged physically in a manner that mimics a daily organizer, such as a calendar or a day-planner, and thus, are not confusing, typically, as to which medication has been designated to be taken at which time(s).
Medication organizing equipment as described above does have disadvantages. Some disadvantages relate to loading the medications into the equipment, and some relate to removing the medications. Further, these manual systems provide only rudimentary record keeping functions. Turning first to the loading disadvantages, many patients are on complicated medication regimes, and thus, it may be complicated to ensure that the correct medication is placed in the compartment that corresponds to the correct time to take that medication. Duplicate pill placement may take place, which may result in an overdose. Or, a placement may be inadvertently omitted, which might result in an under dose. Some patients may find it psychologically daunting to face the task of organizing all of the medications. Or they may simply be unable to do so cognitively, especially if their condition affects their cognition.
Turning to the dispensing disadvantages, a typical day-set contains four compartments, and a typical week-set contains seven day-sets, for a total of twenty-eight dose medication compartments. A patient might become confused as to which medication compartment to use at any given time. Even if not confused, a patient might open a medication compartment from the correct day, but the wrong time, or, perhaps, the correct time, but from the wrong day of the week (for instance, regarding a medication that is taken only every other day, or for three consecutive days, but not the following four). A patient may forget to take any medication at a prescribed time, may open a wrong compartment or may simply not take the medication for another reason. Additionally, a patient might forget that they have taken a given dose of medication, and might take an additional dose. If two people share responsibility for a patient, including, perhaps, the patient himself/herself, both people might give the patient a dose of the same medication, erroneously, resulting in an overdose.
Further disadvantages relate to the lack of real time remote visibility for caregivers or third parties to monitor compliance with the medication schedule. It is also beneficial to generate accurate records reflecting when medication has been taken, or accessed, and what medication has been taken.
In recent years, automated and semi-automated systems have been developed. Many of these systems have disadvantages of their own. They typically have many and complicated features. The user interfaces are overly complicated, and include multiple data read-outs and opportunities for input, similar in complexity to media recording equipment, or kitchen appliances, many of which remain un-programmed, with some features unused. Such systems intimidate and confuse many users, particularly elderly and infirm who require significant amount of medication at specific times. Ironically, the more one is in need of the system, due to the complexity of their drug regime, the greater the probability that they might be unable to use such a modern system. They are difficult to set-up and to program the drug regime. They are sometimes also difficult to use for dispensing medication, because of complex user interaction controls.
Advances in telecommunications have made possible the integration of various systems into smaller devices. Telephones and other handheld electronic devices have been furnished with micro-recording devices, small media recorders and linked to the internet to provide a capability for real-time media links. Vulnerable patients now find themselves in instant communication with service providers in case of accidents. This is particularly useful in promoting independence and self-reliance among those individuals. But while this is convenient, it can lead to a plurality of devices with overlapping telecommunications capabilities, providing potential confusion to less-functional users.
It is therefore desirable to provide a medication dispensing apparatus and system that is straightforward and simple to load with medication. There is also need for such a system from which it is straightforward and simple to dispense medication in proper doses at the proper times. This medication apparatus and system should identify which of many individual dose medication compartments should be used at a given time. It is further desirable that the medical apparatus and system should remind a user that it is time to take medication, and, continue to remind the user until the medication is taken. There is a further need for a system to remind patients to take their medication through various auditory, visual and other cues, and that notifies a third party if the patient does not take the medication or takes the wrong set of medication for a given time period. It is desirable that such a system notifies third parties who are in the same location as the patient, as well as at a distant location if the patient fails to take the required medication. It is desirable that an apparatus in which all of the dose compartments for an entire week, or other long-range time period can be opened and closed together as a group and easily refilled. It is desirable that such a system have a simple user interface, without the need to read text or interpret complex light or sound codes, and that presents minimal or no risk of accidental reprogramming after set-up, and whose setup can be remotely changed in a real-time manner. It is also desirable to reduce the number of devices requiring attention for the convenience of the user (e.g., the patient) and for health and safety. Lastly, it is desirable that such a system provides flexible real time and periodic compliance and non-compliance reporting, and integrates with external medical health record keeping systems.